Kornimate/medical-research-clean huggingface dataset:
evaluation of a preoperative education in total knee arthroplasty

Conditions: Knee Osteoarthritis (Knee OA)

Summary: the benefit of preoperative rehabilitation treatment combining physiotherapy and targeted education for patient undergoing total knee replacement (tkr) is now well known. thus, there is lack of validated booklet containing evidence based informations. our aim is to assess the impact of an evidence based education pre-operative booklet on patient's knowledge and beliefs. the secondary objectives are to assess the impact of the booklet on patient's satisfaction on the information received, the length of stay in orthopedic surgery and the transfer rate to rehabilitation wards. to show a difference of 2 points on the knowledge score (range 0-10) between the two groups, with a = 0.05 and a power of 90%, we considered that 44 patients are needed. the evaluations will take place at baseline, the day before surgery and 6 weeks post-surgery on knowledge and beliefs scores at each visit and on a satisfaction score on the last one. quantitative data will be compared between groups by the kruskal-wallis and qualitative parameters via fisher exact test. the study protocol was approved by the local ethic committee.

the benefit of preoperative rehabilitation treatment combining physiotherapy and targeted education for patient undergoing total knee replacement (tkr) is now well known. thus, there is lack of validated booklet containing evidence based informations. our aim is to assess the impact of an evidence based education pre-operative booklet on patient's knowledge and beliefs. the secondary objectives are to assess the impact of the booklet on patient's satisfaction on the information received, the length of stay in orthopedic surgery and the transfer rate to rehabilitation wards. to show a difference of 2 points on the knowledge score (range 0-10) between the two groups, with a = 0.05 and a power of 90%, we considered that 44 patients are needed. the evaluations will take place at baseline, the day before surgery and 6 weeks post-surgery on knowledge and beliefs scores at each visit and on a satisfaction score on the last one. quantitative data will be compared between groups by the kruskal-wallis and qualitative parameters via fisher exact test. the study protocol was approved by the local ethic committee.

Eligibility criteria:
inclusion criteria: * age ranging from 55 to 75 planned total knee arthroplasty exclusion criteria: * age under 55 or above 75 patients institutionalized patients who have received a total knee arthroplasty of the ipsilateral knee patient not affiliated to a social security scheme (beneficiary or assignee) patients with chronic inflammatory rheumatism cognitive and behavioral issues disorders of understanding and expression of the french language tkr on complex knee

Keywords: • knee osteoarthritis total knee arthroplasty selfcare booklet rehabilitation
effect of sensory integration in diplegic cerebral palsy

Conditions: Diplegic Cerebral Palsy

Summary: the purpose of this study is to compare the effects of sensory integration therapy (sit) applied in addition to neurodevelopmental treatment (ndt) on motor function, balance, and trunk control in diplegia cerebral palsy

cerebral palsy is the most frequent motor disability affecting children. the condition is characterized by problems with postural control and balance, which are due to the central nervous system being compromised by a brain lesion. in sensory processing, the steps include receiving, organizing, and interpreting sensory information, followed by generating an appropriate response. children develop motor skills through sensory experiences. sensory integration therapy leads to enhanced body awareness, motor planning abilities, and coordination between both sides of the body. literature studies have demonstrated the effectiveness of sensory integration therapy in improving motor functions in children with diplegia type cp. however, there is a notable lack of research on how sensory integration therapy, in addition to neurodevelopmental treatment (ndt), affects balance and trunk control in these children. this study aims to bridge this gap by evaluating the impact of sensory integration therapy on gross motor function, balance, and trunk control in children with diplegia type cp when used as an adjunct to ndt.

Eligibility criteria:
inclusion criteria: * participants must be between the ages of 4 and 17. * participants must be classified as level ii, iii, or iv according to the gross motor function classification system (gmfcs). exclusion criteria: * participants who had previously received sensory integration therapy, - undergone botulinum toxin-a injections, or surgical interventions in the past year. * participants who were using pharmacological agents affecting muscle tone. * participants with an uncontrolled history of epilepsy. * participants who were unable to attend the study regularly.

Keywords: cerebral palsy diplegia type treatment balance
defining the risk of ventricular tachycardia in genetic forms of early-onset atrial fibrillation

Conditions: Ventricular Tachycardia; Atrial Fibrillation

Summary: to use programmed ventricular stimulation at the time of af ablation to define the prevalence and mechanism of inducible ventricular tachycardia (vt); pace-mapping to define the site of origin of ventricular arrhythmias; and voltage mapping to define low voltage scar substrate in the basal lv in patients with pathogenic ttn variants compared to genotype-negative controls.

participants will undergo af ablation according to standard, contemporary techniques. the procedure will be performed under general anesthesia. as part of routine standard of care in patients with early-onset af or patients who have pvcs, we will also test for inducibility of vt using a standardized pacing protocol. the research protocol will include lv mapping and identification of low voltage substrate using electroanatomical mapping as described below.

Eligibility criteria:
inclusion criteria: 1. adults aged 18 and older 2. diagnosed with af before age 60 3. scheduled for catheter-based af ablation (de-novo or repeat) 4. able to provide written, informed consent 5. p/lp variant in ttn or other cm gene (cases) or identified as a genotype-negative control. exclusion criteria: 1. diagnosed with a genetic cm or arrhythmia syndrome prior to af 2. vus in 'possibly pathogenic' subgroup (control group only) 3. pacemaker or icd 4. previous pvc or vt ablation 5. lvef \<20% 6. prosthetic mitral or aortic valve 7. contraindication to heparin 8. prior myocardial infarction.

Keywords: catheter ablation genomics
efficacy of oral vancomycin prophylaxis for prevention of recurrent clostridium difficile infection

Conditions: Recurrent Clostridium Difficile Infection; Clostridium Difficile Infection; CDI; C.Difficile Diarrhea; C. Diff Colitis; C.Difficile Colitis

Summary: this study evaluates the efficacy of prophylaxis with oral vancomycin for preventing recurrent clostridium difficile infection (cdi) in patients who have experienced at least one cdi episode in the last 180 days and are receiving antibiotics for a non cdi condition. participants will be randomized to receive either placebo or oral vancomycin in addition to their prescribed antibiotic therapy.

many patients who have a cdi experience recurrent or relapsing symptoms. the investigators are studying whether vancomycin in low doses will help prevent further cdi episodes and how this therapy impacts patients' gastrointestinal microbiome and composition. patients with a history of past cdi who are receiving antibiotics for a non-cdi condition will be invited to participate. approximately half of the participants will receive a low-dose capsule of vancomycin and half will receive a placebo. participants will continue taking the vancomycin/placebo for 5 days after their prescribed antibiotics end.

Eligibility criteria:
inclusion criteria: * willing to provide informed consent. * willing to comply with all study procedures and be available for the duration of the study. * documented diagnosis of at least one cdi within the last 180 days with treatment completed. * currently receiving systemic antibiotics for a non-cdi condition with anticipated duration of no more than 2 weeks. * females of childbearing potential must have a negative pregnancy test prior to randomization and agree to use adequate contraception prior to randomization, for the duration of the study, and for 4 weeks following study completion. * have received no more than 72 hours of non-cdi antibiotics. exclusion criteria: * history of hypersensitivity or allergy to oral vancomycin. * current use of oral vancomycin * patients on concurrent treatment with metronidazole or tetracycline monotherapy for any indication * patients diagnosed with inflammatory bowel disorder (crohn's disease), or bacterial gastrointestinal infection cause by agents other than c. difficile (e.g. salmonella sp.), toxic megacolon and/or known small bowel ileus. * dysphagia (inability to swallow capsules) or unwilling to swallow capsules. * major gastrointestinal surgery within 3 months of enrollment (does not include appendectomy or cholecystectomy). * any history of total colectomy or bariatric surgery. * unable or unwilling to fulfill study requirements. * expected life expectancy \< 6 months. * patients enrolled in another clinical trial with investigational drugs within 30 days prior to randomization. * women who are pregnant or breast-feeding. * any patient deemed not suitable for study participation at the discretion of the study investigator. * diarrhea (3 or more loose stools in a 24 hour period) at enrollment.

Keywords: oral vancomycin vancomycin antibiotic
computerized vestibular rehabilitation

Conditions: Vestibular Diseases

Summary: disorders of vestibular function and balance are an important component of many conditions that commonly affect veterans, such as inner ear diseases, diabetes, and traumatic brain injury. veterans with vestibular impairment have reduced quality of life, limitations on work and physical activities, and an increased risk of falls. the goal of this research is to develop a more engaging and effective interactive tool for vestibular rehabilitation to improve the lives of affected veterans. the first steps in this process will be to test the ability of the application to facilitate vestibular learning and to test its feasibility in vestibular patients. the hypothesis is that computer-game-based adaptation will induce robust vor motor learning and will provide an engaging platform for vestibular rehabilitation. ultimately, our application has the potential to provide more flexible vestibular exercises that will allow therapy to be customized for each patient. it will also have the ability to track a patient's progress over time and to advance exercises as function improves.


Eligibility criteria:
inclusion criteria: * group 1: healthy volunteers: static visual acuity of at least 20/30 at testing distance * group 2: vestibular patients: unilateral or bilateral vestibular hypofunction, no central vestibular disorder, static visual acuity of at least 20/30 at testing distance exclusion criteria: * group 1: peripheral or central vestibular disorder * group 2: central vestibular disorder

Keywords: neurologic rehabilitation computer games
effects of shoes insoles on symptoms and disease progression in knee osteoarthritis

Conditions: Osteoarthritis

Summary: it is hypothesised that laterally wedged insoles will result in reduced knee pain and cartilage volume loss after 12 months of wear, compared to control insoles. people with symptomatic knee osteoarthritis will be recruited from the community and randomised to wear either laterally wedged insoles or control insoles for 12 months. patients will be assessed at baseline and at 12 months.


Eligibility criteria:
inclusion criteria: * eligibility will be confirmed by radiographic and clinical examination * people with medial tibiofemoral joint oa fulfilling american college of rheumatology classification criteria and reporting average knee pain on walking \>3 on an 11-point scale * varus knee malalignment on standing anteroposterior lower limb x-ray. exclusion criteria: * advanced radiographic knee oa (kellgren and lawrence stage 4 * knee surgery or intra-articular corticosteroid injection within 6 months * current or past (within 4 weeks) oral corticosteroid use * systemic arthritic conditions * history of tibiofemoral/patellofemoral joint replacement or tibial osteotomy * any other muscular, joint or neurological condition affecting lower limb function * ankle/foot pathology or pain that precludes the use of insoles * use of foot orthotics within past 6 months and * use of footwear that does not accomodate an insole.
effects of antimuscarinic drugs on overactive bladder (oab) symptoms after insertion of ureteral stents

Conditions: Overactive Bladder

Summary: the purpose of this study is to check whether antimuscarinics that usually broadly used in the treatment of overactive bladder symptoms are effective in the treatment of those symptoms after insertion of ureteral stents. in order to study the efficacy of the treatment of oab symptoms in stented patients the investigator will use a suitable questionnary.


Eligibility criteria:
inclusion criteria: * everyone who underwent ureteral stent insertion and started the treatment with detrusitol exclusion criteria: * adverse affects of detrusitol or unwillness of the patient to continue the treatment with detrusitol, cronic renal or hepatic failure

Keywords: detrusitol overactive bladder ureteral stents
trial of pico versus standard care in chronic and sub-acute wounds

Conditions: Wounds

Summary: randomised controlled trial of pico (a portable negative pressure wound therapy) versus standard care in patients with chronic and sub-acute wounds. sample size 100 patients to investigate time to healing, health economic and patient reported outcomes.

the current study is being conducted to assess the clinical and cost effectiveness of managing patients with a chronic or sub-acute wound in a community setting with pico and to explore the patient experience and issues of concordance that affect patients treated with pico. the study will provide information on the level of clinical benefit that pico can deliver in the population studied in order to justify a sample size for a definitive evaluation of pico and the study will further assess wound types that may benefit from treatment with pico.

Eligibility criteria:
inclusion criteria: * patients \>18 years old * males and females. if female, they must not be pregnant or lactating. if female and of reproductive age, a pregnancy test will be provided. * the patient or their legal representative (if the patient is incapable of giving legal consent), is able to understand the trial and is willing to consent to the trial. * patients with sub-acute or chronic wounds (diabetic foot ulcer, pressure ulcer, venous leg ulcer, or other chronic) suitable for treatment with a pico dressing. * wound duration ≤52 weeks - amended to remove criteria. * wound area range ≥5 cm2 at start of screening period * wound maximum linear dimension ≤ 15cm * able to use english for the interview exclusion criteria: * patients with known allergies to product components (silicone adhesives and polyurethane films (direct contact with wound), acrylic adhesives (direct contact with skin), polyethylene fabrics and super-absorbent powders (polyacrylates) (within the dressing). * wounds which have an infection which is not being treated with systemic antibiotics. * wounds which are actively bleeding. * exposure of blood vessels, organs, bone or tendon at the base of the reference wound * exclude undermining or tunnelling present or suspected in the wound * use of negative pressure device on wound in the last 30 days. amended to remove criteria * malignant wounds/malignancy in the wound * systemic infection not being treated with systemic antibiotics * simultaneous treatment with other experimental wound care procedures, biologics or devices * patients with a known history of poor compliance with medical treatment. * patients who have participated in this trial previously and who closed or were withdrawn. * patients who are unable to understand the aims and objectives of the trial.

Keywords: chronic subacute
effects of vitamin d supplementation on postoperative rehabilitation in hip and knee osteoarthritis patients

Conditions: Osteoarthritis of the Hip or Knee; Joint Arthroplasty

Summary: the goal of this clinical trial is to learn if vitamin d supplementation affects postoperative rehabilitation in osteoarthritis patients who underwent joint arthroplasty. the main questions it aims to answer are: does oral vitamin d supplementation for a period of time after joint arthroplasty affect the postoperative recovery speed in patients who have vitamin d deficiency? does oral vitamin d supplementation after joint arthroplasty affect the long-term recovery of joint functions in patients who have vitamin d deficiency? participants will: take vitamin d oral supplement every day for 3 months. visit the clinic in 1, 3, 6, 12 months after joint replacement surgery for checkups and tests.


Eligibility criteria:
inclusion criteria: 1. vitamin d deficiency (blood 25-hydroxyvitamin d value \< 20ng/ml); 2. meeting the diagnostic criteria for hip or knee osteoarthritis; 3. planning to undergo hip or knee arthroplasty after clinical assessment; exclusion criteria: 1. having other diseases that could cause damage to the bone or cartilage structure of the hip or knee, such as trauma, joint infection, congenital joint malformation, and systemic diseases such as rheumatoid arthritis and gout.
the impact of ocular diseases on driving: a prospective study

Conditions: Macular Degeneration; Glaucoma

Summary: the purpose of the study was (1) to determine thresholds for discriminating speed in peripheral fields of patients with dry amd and (2) to examine the driving skills of licensed drivers with early dry amd using a driving simulator and to investigate how their healthy counterparts perform on the same driving tasks. we hypothesized that speed discrimination may be better in patients with dry amd than in healthy control subjects.

this observational study has two goals: 1. to establish if patients affected by dry amd have a different speed discriminating threshold using peripheral vision fields than their healthy counterparts. 2. to determine if the driving skills of amd and glaucoma patients differ from healthy controls. two tasks will be used: 1) a speed discrimination test. (glaucoma patient are not asked to perform this task as it assesses the peripheral visual fields, which is affected by the disease.) 2) a driving simulation session. participant will undergo both tests on the same day, no later than a month after the initial recruitement visit. for both diseases, patients will be compared to healthy controls matched for age and gender, but also to a younger control group. the latter group was added in order to take into account the normal aging impact on driving skills (visual and cognitive). our hypothesis is that amd patient will show a better speed discriminating threshold than matched control and maybe better or equal to the younger control groups. we also hypothesize that driving skills involving peripheric speed awareness, such as passing another car, will be enhanced in the amd group when compared to glaucoma patients and age-matched control group.

Eligibility criteria:
inclusion criteria: * best-corrected visual acuity (bcva) had to be at least 20/50 (6/15). * binocular visual field (vf) should not be less than 120° along the horizontal meridian and 20° above and below the same meridian. * valid driving license * diagnosis of bilateral dry amd (amd group) or open-angle glaucoma (glaucoma group) exclusion criteria: * diplopia * cognitive impairment * other ocular diseases
lenalidomide plus r-chop for cns relapse prophylaxis in diffuse large b-cell lymphoma

Conditions: Diffuse Large B Cell Lymphoma

Summary: this is an open-label, multicenter, phase 2 trial to explore the efficacy and safety of the combination of lenalidomide and r-chop for preventing the cns relapse in the high-risk diffuse large b cell lymphoma.


Eligibility criteria:
inclusion criteria: age 18-72 years histologically confirmed dlbcl high risk for cns recurrence: cns-ipi:4-6 or involvement of testicular, kidneys or adrenal glands. no pregnancy plans during treatment exclusion criteria: evidence of cns involvement, transformed lymphoma, primary mediastinal b-cell lymphoma ebv+dlbcl, secondary malignancy, hiv positive, creatinine \> 2.0 mg/dl intending to hematopoietic stem cell transplantation history of severe thrombus pregnant or lactating women

Keywords: diffuse large b cell lymphoma central nervous system lenalidomide
effect of functional electrical stimulation on erectile dysfunction

Conditions: Erectile Dysfunction

Summary: objective: the aim of this study is to evaluate the fes effect on erectile function in men with erectile dysfunction. expected results: the hypothesis is that treatment with fes decrease erectile dysfunction.

introduction: erectile dysfunction (ed) affects approximately 150 million men worldwide. the application of functional electrical stimulation (fes) has been used due to the high regenerative capacity of smooth muscle cells. this approach can be beneficial in the treatment of which usually has the ultimate causes cavernous smooth muscle degeneration. objective: the aim of this study is to evaluate the fes effect on erectile function in men with erectile dysfunction. methods: randomized clinical trial will be selected in which 30 patients with erectile dysfunction. the men included will be randomized into two groups. the intervention group will conduct therapy with fes (50hz / 500us) for 15 minutes with intensity below the motor threshold and the control group will use fes placebo. two sessions will be held weekly for four weeks. erectile function will be assessed using the validated questionnaire iief-5. the instrument will be completed by blinded researcher and the technique is randomized and the treatment done randomly. expected results: the hypothesis is that treatment with fes decrease erectile dysfunction.

Eligibility criteria:
inclusion criteria: * male patient * 40 to 65 years of age, with stable marital relationship (6 months) * diagnosis of erectile dysfunction (score of less than 22 iief5) * clinical history of ed for at least 6 months exclusion criteria: * a neurogenic (spinal cord injury, parkinson's, ms, post prostatectomy) * hypogonadism (total testosterone \<300 ng / dl) * patient reporting use of inhibitors or 5pde fic in the last 60 days * diagnosis of coronary artery disease and / or cerebrovascular disease * impossibility of understanding the goals, technical study and informed consent cognitive impairment